Bio-Exercise (BioEx) - A biocreative orofacial myofunctional therapy: preliminary cephalometric study and clinical application

ABSTRACT Objective: To introduce newly structured and developed orofacial myofunctional therapy (OFMFT) protocols named Bio-Exercise (BioEx), and evaluate the treatment effect of this method, using lateral cephalometric analysis on malocclusion with low tongue posture in young patients. Methods: A retrospective preliminary study was performed using orthodontic records from 28 patients (mean age of 8.41±1.45-year-old, 13 males, 15 females) treated with BioEx therapy using tongue elevators for 18.14±9.04 months (range: 6 to 37 months). Pretreatment (T0) and post-BioEx therapy (T1) lateral cephalograms were subsequently analyzed for tongue posture changes by linear, anteroposterior and vertical measurements. The data were analyzed by paired t-test, considering a 5% significance level. Results: The tongue length (TGL) and tongue height (TGH) increased statistically significant between T0 and T1. The decrease of the dorsum of the tongue perpendicular to the palatal plane (Td-PP value) was statistically significant. The increase of the tip of the tongue perpendicular to the pterygomaxillary vertical line (TT-PMV) was not statistically significant. Conclusions: These preliminary cephalometric results indicate that BioEx can be an effective OFMFT modality in increasing the tonicity of the tongue muscles to establish more normalized tongue position at rest.


INTRODUCTION
The Academy of Orofacial Myofunctional Therapy and the Academy of Applied Myofunctional Sciences describe the disturbed and unbalanced orofacial muscular behaviors as orofacial myofunctional disorders. 1 Orofacial myofunctional therapy (OFMFT) is, therefore, a form of physical therapy that enhances functionality of the orofacial muscles encompassing the dental and periodontal structures. 2,3 Re-training or re-directing the muscular activities around the oronasal cavity can promote an environment that supports more stable and balanced occlusions as well as providing solutions to problems that result from weak and uneven biting forces. [1][2][3] The orofacial musculature provides general boundaries to the dentition. The lips and the cheeks support the dentition from outside; and the tongue, from inside. The malfunction of the perioral musculature can create dental and periodontal problems. For example, when the lips are apart and the tongue is overly relaxed in rest, the imbalance between these muscles can affect the positioning of the teeth, resulting in malocclusions, such as the anterior open bite, or interdental spacings. 4 In addition, the orofacial muscular imbalance can be associated with poor speech articulation problems or abnormal swallowing patterns. 1 The purpose of OFMFT, therefore, is to optimize the pressure and the balance of the orofacial muscles that are in proximity of the dentition and the oronasal cavities, to alleviate such issues, based in the Functional Matrix Theory. 5 Moss 5 initially proposed this theory in 1968, and continued Lim LI, Choo HR, Eto LF, Chung KR, Kim SH -Bio-Exercise (BioEx) -A biocreative orofacial myofunctional therapy: preliminary cephalometric study and clinical application 5 to advocate the concept by revising it in 1990s. According to the theory, the growth and development of the orofacial structures are heavily influenced by various neurotrophic responses to the functional needs. The theory emphasizes that the soft tissues surrounding the facial skeletons are critical in signaling the responses to the growth and development of the hard tissues. 5 Since the oronasal functions and the dentitions are closely related, OFMFT aims to guide and develop more harmonious occlusion by normalizing the four major oronasal functions -mastication, speech articulation, swallowing and breathing -through rigorous physical exercises of the tongue and the lip muscles. 1 However, the clinical protocol of OFMFT has not been refined in the clinical practice, and current available protocols tend to demand very high level of cooperation from the patient for a long period of time.
In addition, the physical exercise regimen is very complicated for the patient to follow at home and the care provider cannot verify the level of patient's cooperation because there is no tracking system incorporated in the conventional OFMFT. Patients are, therefore, easily discouraged by the complexity of the therapy and tend to doubt the therapeutic values relative to the financial investment.
Bio-Exercise (BioEx) is a novel OFMFT protocol that is patient-centered and, therefore, easy-to-follow at home. This is an outcome of our efforts to structure and systematize conventional OFMFT protocols while maintaining the high level of therapeutic efficacy.
Lim LI, Choo HR, Eto LF, Chung KR, Kim SH -Bio-Exercise (BioEx) -A biocreative orofacial myofunctional therapy: preliminary cephalometric study and clinical application 6 BioEx utilizes special functional appliances named "BioEx Xenium (BEX)" that were developed by Dr Kyu-Rhim Chung, the founder of Biocreative Orthodontic Strategies in 1980s. 6,7 Thus, the present study aimed to introduce Bio-Exercise as a newly structured OFMFT protocols, and to determine the cephalometric and dimensional effects of this method, using lateral cephalometric analysis on malocclusion with low tongue posture in young patients.

Assessment of orofacial myofunctional disorder (OMD) for BioEx therapy
Assessment of orofacial myofunctional disorder for BioEx therapy is devised based on the reports by Suzuki et al. 8 and Osamu et al. 9 The BioEx OMD assessment is composed of four main categories: (1) Habits, (2) Lip and facial muscles, (3) Tongue and Swallowing muscles and (4) Anatomy. Within these four categories, there are seven topics to assess: 1) Documenting parafunctional oral habits such as thumb/finger sucking, tongue sucking, nail biting, bruxism, tongue thrusting, or others.
2) Recording the chewing styles such as the rubbing tendency of the tongue against the palate, excessive saliva, excessive facial contraction, noisy chewing or occlusal smacking, sticking out of the tongue in receiving the foods.

BioEx and BioEx Xenium (BEX)
The focus of Bio-Exercise is to stimulate the muscular activities around the oronasal cavities, which will improve and maintain the occlusion, as well as to provide a favorable environment for the normal development of the face (Fig 1). The establishment of tonic balance between the lips and the tongue provides an optimal pressure level for a healthy stable occlusion based on the individual needs of the patient. Therefore, BioEx primarily focuses on the trainings of the tongue and lips, and we call this as key soft tissue. One of the major differences that set Bio-Exercise apart from conventional OFMFT is that it utilizes unique removable orthodontic appliances that are designed to help stimulate the orofacial muscles (Fig 2).
These appliances are called Bio-Exercise Xenium (BEX). 6,7,[10][11][12] BioEx is more effective when it is performed while keeping a BEX in the mouth. Examples of BEXs are tongue elevators (Fig 2A), A tongue elevator is one of the most frequently used BEXs and is composed of three primary components: resin body (Forestacryl, Forestadent co., Pforzheim, Germany), occlusal rest and auxiliaries (Fig 2). 6,11,12 A tongue elevator lets the tongue rest on the resin body so that the tongue stays lifted at rest when it is placed in the mouth. The occlusal rests are incorporated in the resin body only when the mandibular molars will benefit from the intrusive force of the tongue's weight. Auxiliaries include a labial bow, screen, and crib. These can be easily modified to custom fit a BEX to meet the patient's specific needs.
Therefore, a tongue elevator has three primary functions:1) lift the tongue effectively, 2) retain the teeth alignment post-orthodontic treatment, and 3) intrude the mandibular molars.

Lip training in BioEx (Lip BioEx)
Lip BioEx is executed with a tongue elevator inside the mouth (Fig 3).
Lip sealing (Fig 3A) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
2) Close the lips so that the lower lip covers the upper lip.
3) Slowly stretch the upper lip down using the lower lip.

4)
Open the mouth to relax the lips and then repeat from the step (2)

5) Repeat 10 times a day.
Posture with cotton roll (Fig 3B) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
2) Place a cotton roll deep in the lower anterior labial vestibule.

3) Close the upper and lower lips together for 5 minutes while
placing the tip of the tongue at the rugae of the anterior palate.

12
Lip massage (Fig 3C) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
2) Stretch down the upper lip to cover the lower lip using the thumb and index finger 3) Open the mouth to relax the lips and then repeat from the step (2)

4) Repeat 5 times a day
Exercises to pronounce the "I" and "U" sounds ( Fig 3D) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
2) Lift the corner of mouth on both sides to make a long "I" sound.
3) Protrude the upper and lower lips as far out as possible to make a long "U" sound.

Tongue training in BioEx (Tongue BioEx, Fig 4)
The following is the BioEx protocol for the tongue training. Similar to the lip training exercise, BioEx for the tongue is executed with a tongue elevator inside the mouth.
Empty swallowing (Fig 4A) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
Lim LI, Choo HR, Eto LF, Chung KR, Kim SH -Bio-Exercise (BioEx) -A biocreative orofacial myofunctional therapy: preliminary cephalometric study and clinical application 2) Push the chin up with a thumb.
3) Swallow with the tongue sealed on the palate as much as possible. It is optional to drink water to stimulate the swallowing motion at this step.

4)
Repeat these steps in front of a mirror, 10 times a day.
Water swallowing (Fig 4B) 1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
2) Pour a small mouthful of water in the mouth and close the mouth to let the molars to contact without any lip restraints.
3) Push the chin up with a thumb.

4)
Swallow with the tongue sealed on the palate as much as possible.

5)
Make sure the lips do not contract during the swallowing.

6)
Repeat these steps in front of a mirror, 10 times a day.

Tongue-palate seal breaker (Fig 4C)
1) Place the tongue elevator inside the mouth. Make sure to let the tongue rest on the tongue elevator's acrylic body comfortably.
2) Seal the tongue on the palate and then make a short suction sound as quickly breaking the tongue seal from the palate.

4)
Repeat these steps 30 times a day.
Lim LI, Choo HR, Eto LF, Chung KR, Kim SH -Bio-Exercise (BioEx) -A biocreative orofacial myofunctional therapy: preliminary cephalometric study and clinical application Place the tongue elevator inside the mouth. Make sure to let the tongue rest comfortably on the tongue elevator's acrylic body.
Read a book out loud for 10 minutes once a week, while keeping a bite stick on the molars on each side simultaneously.

Subjects
A retrospective preliminary study with orthodontic records

Cephalometric analyses of lateral head films
Patients were asked to relax their face and mouth, swallow once   Independent t-test was performed to evaluate sex difference considering a 5% significant level. To check for any significant differences in the measured items as recorded in two different measurements, a paired t-test was performed considering a 5% significance level.

Results
There was no statistically significant difference between male and female group (p>0.5). TGL was defined as the distance between the base of epiglottis (Eb) and TT. The average TGL was 68.19±6.11mm at T 0 and 73.43±7.30mm at T 1 , with the t-value of 5.19 and p<0.001 (Table 1). TGL increased statistically significantly between T 0 and T 1 . TGH was defined as the longest distance between TGL and Td. The average TGH was 25.83±3.45mm at T 0 and 28.13±3.63mm at T 1 with the t-value of 3.96 and p<0.001.
TGH also increased statistically significantly between T 0 and T 1 .
Td-PP was defined as the shortest distance between PP and Td.
The average Td-PP was 7.77±2.95mm at T 0 and 5.80±3.62mm    The superimposition of initial and final cephalometric tracings confirmed improvement of facial development (Fig 8C).   A 4-year-and-11-months-old male child patient was evaluated for an anterior crossbite in the full primary dentition (Fig 9A-E).
The patient was diagnosed to have a skeletal Class III, dental Class III, shown as a mesial step occlusion of the primary dentition, anterior crossbite, large tongue with a thrusting habit, and snoring (Table 3). A BioEx was prescribed using a pair of Class III horseshoe appliances (Forestacryl, Forestadent Co., Pforzheim, Germany) as BEX to stimulate the maxillary protraction (Fig 9F-H). The patient wore the horseshoe appliance with 5/16" 2oz Class III interarch elastics full time. Ten-times of lip sealing was prescribed to strengthen the lower lip muscles. Ten-times of water swallowing exercise was also emphasized to train the tongue tip to touch the palate at rest and during swallowing. The anterior crossbite was corrected with 10 months of BioEx, including an elevated tongue position at rest (Fig 9I-L). In addition, the lower lip showed increased muscle tone. Following these corrections, the Class III horseshoe appliances and tongue elevator combination approach (20min BioEx/day) were replaced by a tongue elevator only, as a second BEX to continue to support the elevated tongue position long-term (Fig 9M). The 10 months BioEx treatment lateral cephalogram and superimposition demonstrate improvement of tongue posture and facial development, when compared with the pretreatment data (Fig 10).     Patients with chronic blockage of the nasal airway by rhinitis, tonsils, or adenoid tend to keep the tongue away from the palate to be able to breathe through the mouth. In addition, hypotonicity of the tongue muscles is another common finding on these patients. Therefore, the tongue muscle training often becomes the primary focus of OFMFT strategies. BioEx is mainly focused to encompass the spectrum from the comprehensive assessment to the patient-oriented self-reporting mechanism, which helps BioEx become an integral part of the full scope of orthodontic and dentofacial orthopedic treatment planning. A tongue elevator is one of the most commonly used BEXs in BioEx because it is designed to significantly elevate the tongue to adjust the tension of the tongue muscles at rest. 6 OFMFT that utilizes BEXs to re-establish the balance among orofacial muscles, with the ultimate goal of improving the skeletal and/or dental relationships. Five elements of BioEx encompasses the spectrum from the comprehensive assessment to the patient-oriented self-reporting mechanism, which helps BioEx become an integral part of the full scope of orthodontic and dentofacial orthopedic treatment planning. This preliminary cephalometric study showed that BioEx affect tongue posture and activity significantly.